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Набор скоро начнётся NCT07564258

Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function

— Наблюдательное Acute Respiratory Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Spontaneous breathing trial.
Кому может быть актуально
Состояния в реестре: Acute Respiratory Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function

Обзор

Occlusion pressure at 100 ms (P0.1) is a reliable and non-invasive index of inspiratory drive that can be measured easily on most ventilator. Unfortunately, P0.1 cannot be measured reliably in non-intubated patients. In those receiving non-invasive ventilation, the measurement of P0.1 might be inaccurate due to leaks. P0.1 cannot be measured at all in patients receiving high-flow nasal canulae (HFNC). Ultrasound indices of diaphragm contractile function, namely diaphragm excursion, velocity and thickening fraction, could be reliable and non-invasive proxies of respiratory drive in non-intubated patient. Our hypothesis is that ultrasound indices of diaphragm function may reliably estimate P0.1. To validate this hypothesis, theses indices will be measured simultaneously with P0.1 in intubated patients, during diaphragm loading conditions similar to spontaneous breathing: the spontaneous breathing trial (SBT). The SBT is used to evaluate if patients can breathe without the assistance provided by the ventilator, and thus, be weaned from mechanical ventilation.

Вмешательства

  • Устройство Spontaneous breathing trial
    A plateau pressure measurement will be performed before starting the spontaneous breathing trial (SBT). Then, immediately and 5, 10, 15, 20, 25, and 30 minutes after the start of the SBT, the following will be performed as part of the study: * Subcostal diaphragmatic ultrasound: M-mode and tissue Doppler * Lateral diaphragmatic ultrasound: 2D mode and M-mode * Measurement of P0.1 * Measurement of Pocc during a tele-expiratory pause, only 5 minutes after the start of the SBT.

Первичные конечные точки

  • P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT [Срок оценки: 5 minutes after the initiation of the SBT]
Вторичные конечные точки (8)
  • P0.1 and EXdi [Срок оценки: Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak contraction velocity [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and EXdi,0.1 [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Velocity Time Integral [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak relaxation velocity [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak relaxation rate [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and TFdi [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and mean thickening velocity [Срок оценки: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]

Критерии участия

Критерии включения

  • \- Age ≥ 18 years old
  • Patient intubated or tracheostomized
  • Decision by the clinician in charge to initiate a SBT
  • After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)

Критерии исключения

  • \- Suspicion of diaphragmatic nerves injury
  • Preexisting neuromuscular disease
  • Spinal cord injury above C5
  • Neuromuscular blockade within last 24 hours
  • Body mass index > 40 kg/m2
  • Pregnancy or breast feeding
  • Patient under legal protection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07564258 · APHP260589

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗